Janssen Research & Development, L.L.C., a Johnson & Johnson company, is looking for a Senior Scientist, Pharmacometrics to be located in Spring House PA, Raritan, NJ or Brisbane or San Diego, CA. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Senior Scientist Pharmacometrics position is responsible for the co-development and execution PK/PD Modeling and Simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of ClinPharm-sponsored and -supported studies for products in any phase of development. Additional responsibilities include the generation and review of clinical pharmacology documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies and Advisory Committee Meetings.
The position is responsible for contributing to and conducting model-based population PK and PK/PD drug development. Individual advancement is based, in part, on the educational background, degree of experience, displaying a progression in the level of expertise and level of independence shown.
· The key tasks can be formulated into 3 main pillars:
· Perform population PK/ PKPD analyses and report writing in support of regulatory submissions.
· Support of “Big Impact” product development projects in all stages of drug development using mechanism-based modeling & simulation methodologies (systems biology, disease progression
· modelling, landscape analysis, etc..) using data acquired at various development stages or using literate searched data.
· Perform exploratory modelling projects asking quick turnaround to support critical business decisions.
· Beyond and as a result of the above, support and input is given into:
· Development and review of ClinPharm Population PK study design sections in clinical trial protocols and assistance is provided to the ClinPharm Leader in the defense of the synopsis and protocols at Synopsis Review Committee (SRC) and Protocol Review Committee (PRC) meetings.
· Assists the ClinPharm Leader in the overall ClinPharm development strategy, the design of specific ClinPharm studies including the design of modeling and simulation-based assessments within clinical Phase 2/3 studies.
· Collaboration, when applicable, with the ClinPharm Leader and ClinPharm Program Manager in the evaluation of Contract Research Organization (CRO) capabilities. Actively participates in the review and monitoring of outsourced Population PK/PD-related activities.
· Working in close collaboration with the Biostatistics and Programming group
· On a more general level:
· Writes population PK/ PKPD analysis plans.
· Development/writing/reviewing (including QC) ClinPharm sections of various internal documents and presentations.
· Establish scientific credibility inside and outside the company (e.g., abstracts, posters, publication in peer reviewed journal, podium presentation at conferences)
· Initiate and contribute to the development of new scientific methodologies, while ensuring high quality standards
· Demonstrates in-depth knowledge/expertise in Clinical Pharmacology and/or associated disciplines by developing scientific projects and effectively applies state-of-the-art scientific knowledge to these projects.
· Supports installation and validation of new and existing software.
· Trains new hires and in-house contractors - related processes
· Carries out functional responsibilities in accordance with applicable SOPs and Regulatory requirements.
· Assists in process improvement initiatives and SOP development.
· Ph.D. Degree with relevant experience (including postdoctoral studies); M.S. Degree, PharmD, or equivalent and at least 2 to 3 years of experience; B.S. Degree with 3 to 5 years of experience performing progressively advanced duties at the Scientist level
· Ability to apply knowledge of clinical PK & PK/PD concepts.
· Experience in 1 or more therapeutic areas
· Has begun to establish a level of expertise or scientific reputation though publications and presentations at external meetings.
· Ability to build and maintain effective working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships)
· Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning, organizing and time management)
· Actively identifying new areas for learning, and application to the job (continuous learning)
· Self-motivated with the ability to work independently with minimal supervision (personal accountability)
· Ability to interface with people of various groups (e.g., clinical, bioanalytical, data management, etc.) and disciplines.
The anticipated base pay range for this position is $111,000 to 170,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. Information on benefits can be viewed by following this link: https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#Pharmacometrics #Exposure-Response #Modeling&Simulation #ClinicalPharmacology